DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species 1 (Figs. 3, 4A-C, 5A-D, and 6A-B), corresponding to claims 1-8 in the reply filed on Jan. 28, 2026 is acknowledged. Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Thus, claims 1-8 are presently pending in this application.
Claim Objections
Claim 8 is objected to because of the following informalities; appropriate correction is required.
Regarding claim 8, the recitation of “the protective wire” should be corrected to, “the protective wires.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0030520 A1 (“Lee”) in view of US 6,264,683 B1 (“Stack”).
Regarding claim 1, Lee discloses a prosthetic heart valve system (abstract), comprising:
a balloon expandable prosthetic heart valve (balloon 28 is inflated to expand prosthetic valve 12, see [0111] and Fig. 11); and
a delivery catheter having a balloon on a distal end portion of the delivery catheter (balloon catheter 16 has inflatable balloon 28 mounted at the distal end, see [0086] and Fig. 1), wherein in a delivery condition of the system and in an activated condition of the system (see Fig. 9 for delivery condition and Fig. 11 for activated condition), the prosthetic heart valve is mounted over the balloon so that a leading edge of the prosthetic heart valve points toward a distal end of the delivery catheter (prosthetic valve 12 can be delivered in a transfemoral procedure, where the inflow (leading) edge of the prosthetic valve is in the left ventricle, thus the leading edge of the heart valve faces toward the distal end, see [0105] and [0110]) and so that the prosthetic heart valve has an outer radial extent (prosthetic valve 12 has an outer radial diameter, see Figs. 9 and 11),
wherein the delivery catheter includes a protective member operably coupled to the delivery catheter (tapered member 126 mounted to inner shaft 34 of balloon catheter 16, see Fig. 9), and in the delivery condition of the system, the protective member does not extend radially beyond the outer radial extent of the prosthetic heart valve (tapered member 126 can have a diameter at its proximal end that is the same as the diameter of the crimped prosthetic valve during the delivery condition, see [0107]).
Lee does not disclose that in the activated condition of the system, the protective member does extend radially beyond the prosthetic heart valve, however Stack discloses a stent delivery catheter that includes an activated condition wherein the protective member does extend radially beyond the outer radial extent of the prosthetic heart valve (stent bumpers 22 and 20 have cylindrical outside surfaces 26 and 24 that are larger than the outside diameter of stent 1 when crimped onto the catheter balloon, see col. 3 lines 2-11 and Fig. 2)
Stack teaches a first stent bumper mounted proximally from the inflatable balloon and a second stent bumper mounted distally from the inflatable member on the catheter, and thus provide more secure stent retention on the ballon and protect the stent from undesirable contact with arterial walls or lesions during placement procedure (see col. 3 lines 2-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery catheter disclosed by Lee to include a protective member that extends radially beyond the outer radial extent of the heart valve in the activated condition, as taught by Stack, in order to better secure the stent to the balloon and protect the stent from contacting the arterial walls or lesions during procedures.
Claims 2-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0030520 A1 (“Lee”) in view of US 6,264,683 B1 (“Stack”), and further in view of WO 2021/247351 A1 (“Costello”).
Regarding claim 2, Lee in view of Stack does not disclose that the delivery catheter includes a plurality of peripheral lumens, however Costello discloses a heart valve delivery system including a plurality of peripheral lumens extending through a sidewall thereof (first and second lumens 738A, 738B extending through inner shaft 732B, see [0004] on pg. 17 and Fig. 7B), and the protective member includes a plurality of protective wires (nosecone 733 includes push wires 750A and 750B, see Fig. 7), each protective wire extending through a corresponding one of the peripheral lumens (push wires 750A and 750B are distally advanced in a longitudinal direction and directed radially outward, see [0003] on pg. 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery catheter disclosed by Lee in view of Stack to include a plurality of protective wires extending through peripheral lumens, as taught by Costello, in order to contact and push against the native anatomy to center the delivery system during the deployed configuration.
Regarding claim 3, Lee in view of Stack does not disclose that the protective wires is formed of a shape memory material, however Costello further discloses that each of the plurality of protective wires is formed of a shape memory material (push wires formed from nitinol, see [0040]).
Costello teaches that push wire 150 may be formed from nitinol in an earlier
embodiment (see [0040]). Costello’s Fig. 7 embodiment similarly discloses push wires 750A and 750B attached to respective cutout portions 735A and 735B, where the push wires include pre-formed bends and are advanced to direct the cutout portions radially outward. Thus, Costello reasonably teaches or at least suggests that the same disclosed push wire made of nitinol material applies to the corresponding push wires 750A and 750B of the similar Fig. 7 embodiment.
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the protective wires disclosed by Lee in view of Stack to be made of a shape memory material, as taught by Costello, as nitinol would predictably provide elastic shape recovery after deployment.
Regarding claim 4, Lee in view of Stack does not disclose that each of the plurality of protective wires had a distal free end, however Costello further discloses that each of the plurality of protective wires had a distal free end (push wires 750A and 750B as previously discussed are distally advanced in a longitudinal direction and directed radially outward, therefore it has a distal free end, see [0003] on pg. 17), the distal free ends being positioned within the corresponding ones of the peripheral lumens in the delivery condition of the system (push wires 750A, 750B with distal cutout portions 735A, 735B are positioned within its corresponding lumen, see Fig. 7 for the delivery configuration), the distal free ends extending beyond the peripheral lumens (push wires 750A, 750B with distal cutout portions 735A, 735B are directed radially outward beyond the lumens, see Fig. 6 for the activated condition shown in a similar embodiment and [0003] on pg. 17) and curling proximally in the activated condition of the system (push wires 750A and 750B curve in opposite ways in the proximal direction, see Fig. 6 for the activated condition shown in a similar embodiment and [0003] on pg. 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the protective wires disclosed by Lee in view of Stack to have a distal free end, as taught by Costello, in order to contact and push against the native anatomy during the deployed configuration.
Regarding claim 5, Lee in view of Stack does not disclose that each of the plurality of protective wires has a fixed distal end to an outer surface of the delivery catheter, however Costello further discloses that each of the plurality of protective wires has a distal end (push wires 750A, 750B have distal ends at distal cutout portions 735A, 735B, see [0003] on pg. 17 and Fig. 7), the distal ends of the protective wires each being fixed to respective point of connection to an outer surface of the delivery catheter (distal ends of push wires 750A, 750B are fixedly connected to its respective cutout portions 735A, 735B of nosecone 733, which is part of the outer surface of the delivery catheter, see [0003] on pg. 17 and Fig. 7) such that a distal portion of each of the plurality of protective wires exits the corresponding one of the peripheral lumens (push wires 750A, 750B with distal cutout portions 735A, 735B are directed radially outward beyond the lumens, see Fig. 6 for the activated condition shown in a similar embodiment and [0003] on pg. 17) and turns proximally to the point of connection (push wires 750A, 750B curve in opposite ways in the proximal direction toward the inner shaft 732, see Fig. 6 for the activated condition shown in a similar embodiment and [0003] on pg. 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal ends of the protective wires disclosed by Lee in view of Stack to have it fixedly connected to the catheter’s outer surface, as taught by Costello, in order to contact and push against the native anatomy during the deployed configuration.
Regarding claim 6, Lee in view of Stack does not disclose wherein the protective member is a protective wire having a main shaft and a plurality of distal wire end portions forming an umbrella shape, however Costello further discloses that the protective member is a protective wire having a main shaft (push wires 750A and 750B has inner shaft 732B, see Fig. 7B) and a plurality of distal wire end portions extending from the main shaft (cutout portions 735A and 735B on the distal end portions of push wires 750A and 750B can extend radially outward from inner shaft 732B, see [0003] and [0004] on pg. 17), the distal wire portions forming an umbrella shape (push wires 750A and 750B with cutout portions 735A and 735B are distally advanced in a longitudinal direction and then directed radially outward in the proximal direction to form a generally convex contour or umbrella shape, see [0003] on pg. 17 and Fig. 6 for the activated condition shown in a similar embodiment and Fig. 7 for the delivery condition) in the absence of applied forces (pre-formed bend 751A and 751B directs the cutout portions 735A and 735B radially outward to bend or curve in opposing direction without applied forces).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the protective member disclosed by Lee in view of Stack to be a protective wire with distal wire portions forming an umbrella shape, as taught by Costello, in order to contact and push against the native anatomy to center the delivery system during the deployed configuration.
Regarding claim 7, Lee in view of Stack does not disclose a covering material, however Costello further discloses a covering material coupled to the distal wire portions of the protective wire (cutout portions 735A and 735B are coupled to the distal wire portions of push wires 750A and 750B, see Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the delivery system disclosed by Lee in view of Stack to have a covering material coupled to the distal wire portion of the protective wire, as taught by Costello, in order for the outer surface of the cutout portions to be flush with the outer surface of the nosecone during the delivery configuration, and be able to advance radially outward during the deployed configuration.
Regarding claim 8, Lee in view of Stack does not disclose that in the activated condition of the system, the distal wire portions of the protective wire overlie the leading edge of the prosthetic heart valve, however Costello further discloses that the distal wire portions of the protective wire overlie the leading edge of the prosthetic heart valve in the activated condition of the system (cutout portions 735A and 735B of push wires 750A and750B lie over the leading edge of the prosthetic heart valve after it has been directed radially outward during the activated condition, see Fig, 7 and Fig. 6 for the activated condition shown in a similar embodiment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal wire portions of the protective wires disclosed by Lee in view of Stack to overlie the prosthetic heart valve, as taught by Costello, in order to contact and push against the native anatomy to center the delivery system during the deployed configuration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 2007/0055340 A1 (Pryor) teaches a stent delivery system wherein each of the plurality of protective wires is formed of a shape memory material (pullwires 120a and 120b may be formed of nickel-titanium alloy and/or polyurethane, see [0024]).
US 2019/0105465 A1 (“Erbey, II”) teaches a ureteral catheter (catheter device 10, see Fig. 1K) including multiple coiled drainage lumens (218, see Fig. 1K) with a plurality of coils (244) partially extend from a shaft (tube 12) to curl in the proximal direction (see Fig. 1K).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHA UYEN C NGUYEN whose telephone number is (571)272-3399. The examiner can normally be reached Monday-Friday 8:30-5:30pm.
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/N.C.N./Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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